Nivolumab

The Basics

What is Nivolumab?

Used to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.

Brand names for Nivolumab

Opdivo

How Nivolumab is classified

Antineoplastic Agents, Biological Response Modifiers, Immunologic Adjuvants, Immune Checkpoint Inhibitors, Antibodies – Monoclonal

Nivolumab During Pregnancy

Nivolumab pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Nivolumab while pregnant

Based on data from animal studies and its mechanism of action [see CLINICAL PHARMACOLOGY], OPDIVO can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see Data). Human IgG4 is known to cross the placental barrier and nivolumab is an immunoglobulin G4 (IgG4); therefore, nivolumab has the potential to be transmitted from the mother to the developing fetus. The effects of OPDIVO are likely to be greater during the second and third trimesters of pregnancy. There are no available data on OPDIVO use in pregnant women to evaluate a drug-associated risk. Advise pregnant women of the potential risk to a fetus. The background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Taking Nivolumab While Breastfeeding

What are recommendations for lactation if you're taking Nivolumab?

No information is available on the clinical use of nivolumab during breastfeeding. Because nivolumab is a large protein molecule with a molecular weight of 146,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, nivolumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during nivolumab therapy and for 5 months after the last dose of the drug.

Maternal / infant drug levels

No information is available on the clinical use of nivolumab during breastfeeding. Because nivolumab is a large protein molecule with a molecular weight of 146,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, nivolumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during nivolumab therapy and for 5 months after the last dose of the drug.

Possible effects of Nivolumab on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Nivolumab

None listed